Management of New-Onset Postoperative Atrial Fibrillation (Monitor-AF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01395836
Recruitment Status : Completed
First Posted : July 18, 2011
Last Update Posted : November 4, 2016
Information provided by (Responsible Party):
Mikhael El Chami, Emory University

Brief Summary:
One common occurrence following open heart surgery is an irregular rhythm from the top chambers of the heart known as atrial fibrillation (afib or AF). It is known that about 30% of patients who have had bypass surgery without having a heart valve replaced at the same time will develop AF. It is felt that this occurrence leads to factors that will affect a subjects health for the rest of their life. In studying this the investigators will see if post operative afib is an indicator of a person having afib and is not a condition that may only last during the post op recovery period as many physicians feel.The problem in question is, is post operative afib only transient or is it an indicator for more long term episodes of afib that may lead to other health concerns like stroke. Fifty subjects will be asked to participate. There will be to groups of 25 subjects. All subjects will have a device implanted under the skin that will be able to detect all types of heart rhythms. One group will get standard treatment and the physicians will be blinded to the recordings. The other group will be treated by the recording and the information about the amount of time in afib. The purpose of the study is to determine what the true occurrence of afib is for the first year after open heart surgery and to see if knowing this will alter the clinical management of this group of subjects.Currently most subjects are treated without knowing this information and based on that the arrhythmia will no longer happen after the heart is healed or recovered from the surgery. Most medications for controlling the heart rate and rhythm are stopped around 3 months. There is also a tendency to not to use blood thinning medications for the prevention of stroke after this time period. Stroke is one of the major complications from afib. Not all subjects are aware of the irregular heart beats so you can not depend on them to accurately know. They might feel episodes of very fast beating episodes or may become weak and fatigued. Weakness and fatigue are also normal during the first parts of recover from bypass surgery. By documenting the true episodes of afib the investigators can better understand if postoperative afib might need to be treated as a life long issue rather than a transient post operative issue. This treatment might change clinical management and decrease mortality.

Condition or disease
Atrial Fibrillation Coronary Artery Disease Post Operative Arrythmia

Study Type : Observational
Actual Enrollment : 23 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Management of New-Onset Postoperative Atrial Fibrillation Utilizing Insertable Cardiac Monitor Technology to Observe Recurrence of AF
Study Start Date : October 2011
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

The "treatment" group will be medically managed based on data obtained from monthly transmissions of the implanted Cardiac Monitor.
Control Group
The "control" group will be managed in the usual standard of care with physicians blinded to their ICM data.

Primary Outcome Measures :
  1. The presence of AF at any post-operative points in time. [ Time Frame: 3 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing isolated CABG at Emory University Hospital Midtown will be followed post-operatively and screened for inclusion to the trial.

Inclusion Criteria:

  • Subject is able and willing to sign and date the Patient Consent Form.
  • Subject is 18 years of age or older.
  • Subject is expected to remain available for at least 12 months of follow- up visits.
  • Subject is willing to comply with the protocol, including follow-up visits, medication compliance, carelink transmissions, and randomization assignment.
  • Subject has a CHADS2 score of ≥ 1.
  • Subject is hospitalized post isolated CABG or is within 72 hours post hospital discharge from a CABG procedure.
  • Subject has no previous history of AF and has developed new-onset postoperative atrial fibrillation according to the established STS definition, which defines it as the occurrence of POAF or atrial flutter requiring treatment (i.e. beta-blockers, calcium-channel blockers, amiodarone, anticoagulation, or cardioversion).

Exclusion Criteria:

  • Subject has a medically documented history of paroxysmal or persistent atrial fibrillation or atrial flutter.
  • Subject is pregnant.
  • Subject is enrolled or planning to participate in a concurrent drug and/or device study during the course of this study that would confound study results as determined by the study physician.
  • Subject has previously or is scheduled to undergo valve repair or valve replacement during the course of the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01395836

United States, Georgia
Emory University Hospital Midtown
Atlanta, Georgia, United States, 30308
Sponsors and Collaborators
Emory University
Principal Investigator: Mikhael F El Chami, MD Emory University

Publications of Results:
Responsible Party: Mikhael El Chami, Associate Professor, Emory University Identifier: NCT01395836     History of Changes
Other Study ID Numbers: IRB00047554a
EPEUHM ( Other Identifier: Other )
First Posted: July 18, 2011    Key Record Dates
Last Update Posted: November 4, 2016
Last Verified: November 2016

Keywords provided by Mikhael El Chami, Emory University:
Coronary Artery Bypass Grafting
Cardiac Electrophysiology
Cardiac Surgery

Additional relevant MeSH terms:
Atrial Fibrillation
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Arterial Occlusive Diseases
Vascular Diseases